USFDAJun 24, 2026, 07:31 AM
Cognition Therapeutics gets FDA alignment for pivotal DLB psychosis trial
AI Summary
Cognition Therapeutics announced it received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, zervimesine. The FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an approvable outcome and aligned with the company on key aspects of a pivotal trial design. The registrational program is expected to commence in mid-2027, with a Phase 3 study enrolling DLB patients experiencing psychosis symptoms. This development follows promising Phase 2 results where zervimesine slowed the progression of hallucinations and delusions by 89%.
Key Highlights
- FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an approvable outcome.
- FDA aligned with Cognition Therapeutics on key aspects of a pivotal trial design for zervimesine.
- The registrational program for zervimesine is expected to begin in mid-2027.
- The Phase 3 study will enroll DLB patients with psychosis, randomized for nine months.
- Cognition will work with FDA on using the neuropsychiatric inventory (NPI) as a novel primary endpoint.
- Phase 2 SHIMMER trial showed zervimesine slowed progression of hallucinations and delusions by 89%.
- Zervimesine aims to be the first long-term, durable treatment option for DLB psychosis.
Price Impact
More from CGTX